Safety of Cold-Adapted Live Influenza Vaccine

Wp, Glezen; Pa, Piedra; Im, Longini; Me, Halloran

doi:10.1097/00006454-200406000-00030

Cited by 3 publications

(2 citation statements)

References 3 publications

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“…Misclassification of asthma in young children may explain the discrepant data. 45 More than 1500 comparisons were made without adjustments for multiple comparisons. For independent outcomes at an ␣ level of .10, a mean of 150 positive tests are expected for when there is no difference in rates between LAIV-T and placebo.…”

Section: Discussionmentioning

confidence: 99%

“…For independent outcomes at an ␣ level of .10, a mean of 150 positive tests are expected for when there is no difference in rates between LAIV-T and placebo. 27,45 For dependent outcomes, the number of statistically significant results expected as a result of chance alone may be more or less depending on the degree of dependence and the nature of the true association of the vaccine with the outcome. In no other clinical trials has an increased risk for asthma in healthy LAIV-T vaccinees been observed.…”

Section: Discussionmentioning

confidence: 99%

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Live Attenuated Influenza Vaccine, Trivalent, Is Safe in Healthy Children 18 Months to 4 Years, 5 to 9 Years, and 10 to 18 Years of Age in a Community-Based, Nonrandomized, Open-Label Trial

Piedra

Gaglani²,

Riggs

et al. 2005

Pediatrics

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ABSTRACT. Objective. Influenza-associated deaths in healthy children that were reported during the 2003-2004 influenza season heightened the public awareness of the seriousness of influenza in children. In 1996 -1998, a pivotal phase III trial was conducted in children who were 15 to 71 months of age. Live attenuated influenza vaccine, trivalent (LAIV-T), was shown to be safe and efficacious. In a subsequent randomized, double-blind, placebo-controlled LAIV-T trial in children who were 1 to 17 years of age, a statistically significant increase in asthma encounters was observed for children who were younger than 59 months. LAIV-T was not licensed to children who were younger than 5 years because of the concern for asthma. We report on the largest safety study to date of the recently licensed LAIV-T in children 18 months to 4 years, 5 to 9 years, and 10 to 18 years of age in a 4-year (1998 -2002) community-based trial that was conducted at Scott & White Memorial Hospital and Clinic (Temple, TX).Methods. An open-label, nonrandomized, communitybased trial of LAIV-T was conducted before its licensure. Medical records of all children were surveyed for serious adverse events (SAEs) 6 weeks after vaccination. Health care utilization was evaluated by determining the relative risk (RR) of medically attended acute respiratory illness (MAARI) and asthma rates at 0 to 14 and 15 to 42 days after vaccination compared with the rates before vaccination. Medical charts of all visits coded as asthma were reviewed for appropriate classification of events: acute asthma or other. We evaluated the risk for MAARI (health care utilization for acute respiratory illness) 0 to 14 and 15 to 42 days after LAIV-T by a method similar to the postlicensure safety analysis conducted on measles, mumps, and rubella and on diphtheria, tetanus, and whole-cell pertussis vaccines.Results. All children regardless of age were administered a single intranasal dose of LAIV-T in each vaccine year. In the 4 years of the study, we administered 18 780 doses of LAIV-T to 11 096 children. A total of 4529, 7036, and 7215 doses of LAIV-T were administered to children who were 18 months to 4 years, 5 to 9 years, and 10 to 18 years of age, respectively. In vaccination years 1, 2, 3, and 4, we identified 10, 15, 11, and 6 SAEs, respectively. None of the SAEs was attributed to LAIV-T. In vaccination years 1, 2, 3, and 4, we identified 3, 2, 1, and 0 pregnancies, respectively, among adolescents. All delivered healthy infants. The RR for MAARI from 0 to 14 and 15 to 42 days after LAIV-T was assessed in vaccinees during the 4 vaccine years. Compared with the prevaccination period, there was no significant increase in risk in health care utilization attributed to MAARI from 0 to 14 and 15 to 42 days after vaccination in children who were 18 months to 4 years, 5 to 9 years, and 10 to 18 years of age in the 4 vaccine years. In children who were 18 months to 4 years of age, there was no significant increase in the risk in health care utilization for MAARI, MAARI subcategorie...

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Live Attenuated Influenza Vaccine, Trivalent, Is Safe in Healthy Children 18 Months to 4 Years, 5 to 9 Years, and 10 to 18 Years of Age in a Community-Based, Nonrandomized, Open-Label Trial

Piedra

Gaglani²,

Riggs

et al. 2005

Pediatrics

Self Cite

View full text Add to dashboard Cite

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Current awareness: Pharmacoepidemiology and drug safety

2004

Pharmacoepidemiology and Drug

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In order to keep subscribers up‐to‐date with the latest developments in their field, John Wiley & Sons are providing a current awareness service in each issue of the journal. The bibliography contains newly published material in the field of pharmacoepidemiology and drug safety. Each bibliography is divided into 20 sections: 1 Books, Reviews & Symposia; 2 General; 3 Anti‐infective Agents; 4 Cardiovascular System Agents; 5 CNS Depressive Agents; 6 Non‐steroidal Anti‐inflammatory Agents; 7 CNS Agents; 8 Anti‐neoplastic Agents; 9 Haematological Agents; 10 Neuroregulator‐Blocking Agents; 11 Dermatological Agents; 12 Immunosuppressive Agents; 13 Autonomic Agents; 14 Respiratory System Agents; 15 Neuromuscular Agents; 16 Reproductive System Agents; 17 Gastrointestinal System Agents; 18 Anti‐inflammatory Agents ‐ Steroidal; 19 Teratogens/fetal exposure; 20 Others. Within each section, articles are listed in alphabetical order with respect to author. If, in the preceding period, no publications are located relevant to any one of these headings, that section will be omitted.

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Influenza vaccine in patients with asthma

Hanania

Atmar

Castro

2006

Expert Review of Vaccines

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Influenza virus continues to be a major cause of respiratory infection and is an important contributor to morbidity and mortality in at-risk populations, including those with underlying pulmonary conditions such as asthma. Vaccination with inactivated influenza vaccine remains the most popular method in controlling influenza through prevention. Current guidelines recommend the administration of the influenza vaccine to all patients with asthma. However, a third or fewer of those patients with asthma are currently receiving this vaccine. In this review, the risk-versus-benefit of influenza vaccination in children and adults with asthma is evaluated, based on the current evidence.

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Safety of Cold-Adapted Live Influenza Vaccine

Cited by 3 publications

References 3 publications

Live Attenuated Influenza Vaccine, Trivalent, Is Safe in Healthy Children 18 Months to 4 Years, 5 to 9 Years, and 10 to 18 Years of Age in a Community-Based, Nonrandomized, Open-Label Trial

Live Attenuated Influenza Vaccine, Trivalent, Is Safe in Healthy Children 18 Months to 4 Years, 5 to 9 Years, and 10 to 18 Years of Age in a Community-Based, Nonrandomized, Open-Label Trial

Current awareness: Pharmacoepidemiology and drug safety

Influenza vaccine in patients with asthma

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